Medical device manufacturer, Philips Healthcare issued a field safety notice concerning all Pinnacle3 software with versions 9, 9.2, and 9.4.
A problem has been detected in the Philips Pinnacle3 software that, if it were to re-occur, could affect the performance of the equipment. Under certain conditions in Pinnacle3 9, 9.2, and 9.4, users can modify the geometry of a beam or change the parameters for a bolus and the software does not invalidate the control point dose.
Philips Healthcare is distributing an addendum to the Pinnacle3 instructions for use (IFU) which describes how to explicitly invalidate control point dose in this situation. The underlying issue is corrected in Pinnacle3 9.6.
The manufacturer recommends customers to review the information contained in the notice including the IFU addendum with all members of the staff who need to be aware of their contents and retain a copy of the addendum with the Pinnacle3 9, 9.2, and 9.4 IFU.
According to the local supplier, the affected products were distributed in Hong Kong.
If you are in possession of the affected product, please contact your supplier for necessary actions.
Posted on 08 May 2013